Vice President Medical Services and Strategy

Novotech; Raleigh (NC); Vor Ort; USD 350.000 - 399.000; Vollzeit

Benefits dieser Stelle

Flexible working options

Paid parental leave

Wellness programs

Ongoing development programs

Circle Back Initiative Employer

Zusammenfassung

Novotech is seeking a Global Head of Medical Services based in the United States to lead physicians across North America, Europe, and APAC. This role demands a global mindset, strong leadership, and a commitment to excellence in medical governance and patient safety, with responsibility for the division's profitability.

You will guide a team of medical advisors, collaborate with the CMO and other senior leaders, oversee medical monitoring, regulatory compliance, and cross-functional trial

Qualifikationen

• MD or equivalent medical degree; USA-based.
• 15+ years in a medical role within industry (pharma/biotech/CRO).
• Strong knowledge of clinical trial regulations (GCP/ICH) and safety reporting.
• Proven leadership and global team management experience.
• Strong business acumen and strategic thinking.

Aufgaben

• Lead medical services globally across NA, Europe, and APAC.
• Oversee medical monitoring, safety governance, and clinical trial oversight.
• Manage budgets, resource allocation, and department P&L.
• Collaborate with CMO and senior leaders to drive growth and profitability.
• Develop and mentor medical advisors and cross-functional teams.

Kenntnisse

MD/Medical Doctor

15+ years experience

Global leadership

Communication skills

Business acumen

GCP/ICH regulatory knowledge

Ausbildung

MD or equivalent medical degree (USA)

Tools

Clinical data safety databases

Jobbeschreibung

About the Role

As a global CRO, we are looking for a highly qualified and experienced Global Head of Medical Services to manage all physicians across North America, Europe, and APAC. The ideal candidate will have a global mindset, strong leadership skills, commitment to excellence in medical governance and the protection of human safety, and strong business acumen. This role will be accountable for the division's Profit and Loss.

This is a senior leadership position within Novotech based in the United States. This role is accountable for the global organization encompassing the Medical Services group that provides medical monitoring services and clinical development advice. This role will ensure the highest standards of medical and safety governance and oversight for all medical activities executed within the organization. In addition, this role will be responsible for the financial performance of this global function. This role plays a pivotal role in providing strategic direction, leadership, and guidance to a team of medical advisors, and collaborates closely with other departments to support the successful execution of clinical trials.

Responsibilities

Leadership and Strategy

• Optimize and implement the medical monitoring strategy in alignment with the company's overall goals and objectives.
• Provide visionary leadership to the medical advising team, fostering a culture of excellence, innovation, and continuous improvement.
• Collaborate with the CMO and other senior leadership to drive the organization's growth and profitability.

Medical/Clinical Oversight

• Act as the point of escalation for medical and safety issues related to clinical trials, serving as an expert resource for the organization.
• Ensure the highest standards of medical and safety monitoring for patient safety in clinical trials, from early-phase studies to late-phase trials.
• Review and approve project scope and budgets with respect to medical services.

Team Management

• Recruit, develop, and manage a team of medical advisors, providing guidance, mentorship, and professional development opportunities.
• Oversee the day-to-day operations of the Medical Services department, including policy and procedure, workload management and resource allocation.

Regulatory Compliance

• Stay current with ICH/GCP and relevant regulatory requirements and guidelines related to clinical trials and medical monitoring, ensuring the company's adherence to all applicable regulations and standards.
• Provide strategic oversight of quality risk management, supporting proactive identification, mitigation and escalation of significant quality and compliance risks associated with:
  • Clinical trials.
  • Company policies and procedures.
• Partner with Quality Assurance and other functions to provide medical leadership and oversight of quality risk management, ensuring medical and patient safety risks are proactively identified, assessed, mitigated and appropriately escalated.

Cross-functional Collaboration

• Work cross -functionally (project management, clinical operations, data management, biostatistics, and regulatory affairs etc.) to ensure seamless execution of clinical trials.
• Work closely with commercial teams and the Medical and Scientific Strategists and Drug Development Consulting groups to cultivate sponsor relationships that contribute to study awards.
• Foster strong working relationships with external medical experts and Key Opinion Leaders (KOLs).
• Foster strong working relationships with external sites and investigators
• Foster strong working relationships with physician staff within our sponsor partners

Quality Assurance

• Implement and oversee quality control measures to maintain the highest standards of medical monitoring and safety.
• Develop and monitor key performance indicators (KPIs) to assess the effectiveness of medical monitoring activities.
• Manage the department's budget, ensuring cost-effective allocation of resources and optimal financial performance.
• Mange the department's profit margins, utilization, and realization.

Experience & Qualifications

• Medical Doctor (MD) or equivalent medical degree in the United States.
• Significant experience (typically 15+ years) in a medical role in industry (large pharm, biotech, CRO)
  • Including experience in medical monitoring, clinical development, and leadership roles.
• Strong understanding of clinical trial regulations, Good Clinical Practice (GCP), and safety reporting requirements.
• Proven leadership and team management skills. A history of global leadership preferred
• Strong Business acumen
• Excellent communication, negotiation, and problem-solving abilities.
• Ability to work effectively in a fast-paced and dynamic environment.
• Advanced knowledge of clinical data and safety databases is a plus.

Expected Salary Range: $350K to $399K USD - Salary offered will be based on candidates experience level.

Find out more about working at Novotech at: www.novotech-cro.com/careers

Novotech is proud to offer a great workplace. We are committed to being an employer of choice for gender equality and providing an inclusive work environment where everyone is treated fairly and with respect.

Our team members are passionate about what we do, but we understand work is only of the things that is important to them. We support our team members with flexible working options, paid parental leave for both parents, flexible leave entitlements, wellness programs and ongoing development programs.

We are looking for people who are passionate about working clinical research and biotech, including people who identify as LGBTIQ+, have a disability or have caring responsibilities.

We are a Circle Back Initiative Employer and commit to respond to every application. We look forward to contacting you regarding your application.